The results of a pivotal global Phase III study on Fycompa (perampanel) from Japanese drugmaker Eisai (TYO: 4523) in primary generalized tonic-clonic seizures showed that one third more patients treated with the drug experience a 50% responder rate, statistically significant versus placebo.
It also demonstrated a reduction in primary generalized tonic-clonic seizure frequency per 28 days versus placebo. When treated with Fycompa as an adjunctive therapy, 31% of patients are seizure-free during the 13-week maintenance period compared to 12% in the placebo group.
The adverse event profile is similar to that of other studies on perampanel, with the most common adverse events being dizziness, fatigue, headache, somnolence and irritability. Perampanel was well-tolerated and improves the control of this kind of seizure in patients still experiencing seizures despite current treatment.
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